In this webinar, the attendees will gain insights into the latest research methodologies used to optimize central nervous system (CNS)-targeted drug delivery.
A key highlight of the webinar will be the presentation of novel data from a pilot study. This study utilized adeno-associated virus (AAV)-based gene therapy with fluorescent tagging, allowing for advanced visualization of biodistribution through histological and tomography-based imaging techniques.
During the webinar, the speakers will discuss a groundbreaking approach where a fluorescent-tagged transgene was delivered via AAV to the brain, enabling visualization using histological techniques and tomography imaging. This innovative approach allowed researchers to generate highly detailed 3D reconstructions of biodistribution patterns, layered with magnetic resonance imaging (MRI) anatomical data to create a comprehensive visualization of gene transport. This type of data is invaluable for researchers designing CNS-targeted drug delivery programs as it provides both qualitative and quantitative insights into treatment efficacy and precision.
The webinar will also address translational considerations for CNS drug delivery. The speakers’ insights will be particularly valuable for professionals looking to bridge the gap between preclinical research and clinical implementation.
Register for this webinar to gain a clear understanding of how to design more effective CNS drug delivery studies and avoid common pitfalls in the field.
Speakers
Jake McDonald, PhD, ATS, CEO, Envol Biomedical
Dr. Jake McDonald is the current Chief Executive Officer for Envol Biomedical. Dr. McDonald has over 25 years of experience in contract research. Prior to Envol, Dr. McDonald was Chief Scientific Officer and Vice President of Lovelace Biomedical Research Institute, where he oversaw all nonclinical contract research activities.
Dr. McDonald was involved in the conversion of Lovelace from non-GLP to GLP for pharmaceutical studies and led the efforts to expand and develop/convert the business model to support the pharmaceutical industry in pharmacology and toxicology models. He has over 180 peer-reviewed publications, one book chapter and has served as a Key Opinion Leader in toxicology, risk assessment and drug development for acadamia, government and biotechnology companies.
He has a PhD in Chemistry and Toxicology from the University of Nevada, Reno. He has served on three National Academy of Science Panels and numerous Scientific Review panels and is a Fellow of the Academy of Toxicologic Sciences. At Envol, Dr. McDonald and the team are developing a leading Nonhuman Primate research facility with world-class capabilities in pharmacology and toxicology.
Message Presenter
Dr. Rainier Espinoza, Lead Surgeon and Study Director, Envol Biomedical
With over a decade of experience in the medical and scientific fields, Dr. Rainier Espinoza is a study director at Envol Biomedical, a leading company in developing novel therapies for central nervous system disorders. He conducts nonclinical laboratory studies, from writing study protocols and approving final reports, to communicating with sponsors and ensuring compliance with legislation. Rainier’s passion is to advance scientific knowledge and improve the quality of life for patients with neurological conditions.
As a Former Internal Medicine and Intensive Care Physician, a Neurosurgeon and a Clinical Researcher, he has a strong background in designing, implementing and overseeing clinical protocols, data analysis and reporting. He has successfully completed multiple clinical trials as a Medical Advisor, Medical Monitor, and Primary Surgeon. Rainier has also obtained certifications in intensive care, case management and good clinical practice. As a bilingual professional, fluent in Spanish and English, Rainier is a collaborative team player, committed to delivering excellence and innovation in the field of neuroscience.
Message Presenter
Dr. Ernesto Salegio, PhD, Vice President, Segment Leader Translational & Pre-Clinical Research, ClearPoint Neuro
Dr. Ernesto Salegio joined ClearPoint Neuro in March 2021. He brings over 20 years of experience in translational neuroscience with direct pre-clinical neurosurgery expertise delivering therapeutics to the brain, spinal cord and cerebrospinal fluid. He has over 16 years of combined experience in the field of AAV gene therapy, stem cell therapy, image-guided platforms, small/larger molecules and neurodegenerative disorders.
Dr. Salegio has served as a Study Director for more than 11 years in non-GLP studies, as well as in safety/tox GLP studies and has worked with industry and academic partners from study conception to IND-approval. During his career, he has led cross-functional teams, strategic partnerships, studies investigating novel therapeutics (AAV libraries), biomarker identification indicative of therapeutic benefit and device development of MRI-compatible hardware. He has authored more than 32 peer-reviewed publications and holds a bachelor’s in Behavioral Psychology, a Bachelor’s in Neuroscience (with honors) and a PhD in Neuroscience/Inflammation from Flinders University of South Australia.
Message PresenterWho Should Attend?
This webinar will appeal to those working in the following areas or having the following job titles:
- Preclinical Pharmaceutical Scientists
- Drug development professionals in biotech and pharmaceutical industries
- Researchers focusing on pharmacology, pharmacokinetics, biodistribution or toxicology of CNS-targeted therapies
- Neuroscientists/Clinicians interested in cutting-edge CNS drug delivery methodologies
What You Will Learn
Attendees will learn about:
- Techniques for direct injection into specific brain regions and intrathecal spaces
- Measurement of biodistribution and biological endpoints in CNS studies
- Novel techniques in visualizing gene transport using fluorescent tagging and tomography imaging
- The role of MRI guidance in ensuring accurate drug delivery and minimizing off-target effects
- Insights into designing effective CNS-targeting programs
Xtalks Partner
ENVOL
ENVOL is a French word that means to take off, and soar. The name symbolizes what we represent as a company, and how we envision our collaboration with our clients will help enable their technologies. Envol Biomedical, established in 2019, is a growing preclinical contract research organization with a mission to be the leading nonhuman primate research facility in the country for the pharmaceutical industry. The company has access to the largest population of NHP in the US, with lead times for new studies of 4-6 weeks. The laboratory has capabilities in multiple dose routes (including CNS, ophthalmic), specialized disease models and surgical collections. We have access to NHP resources that include cynomolgus macaque of numerous origins, marmosets, squirrel monkeys and African Green. The laboratory is supported by a clinical pathology and immunology core laboratory. Envol is AAALAC accredited, USDA and OLAW compliant. Our business model is to provide our clients a high value research partner through speed, customer service and quality. We have a strong workforce that is managed by a leadership team with significant CRO and pharmaceutical industry experience. Envol aims to be GLP compliant in 2025.
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